← Product Code [LZA](/productcode/LZA) · K201857

# Powder Free Nitrile Examination Glove Black and Dual Color White-Blue (K201857)

_Careplus (M) Sdn Bhd · LZA · Aug 20, 2021 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K201857

## Device Facts

- **Applicant:** Careplus (M) Sdn Bhd
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Aug 20, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

## Device Story

Disposable nitrile examination gloves; ambidextrous; available in black or dual-color white-blue. Manufactured via double-dipping for dual-color variant. Used in clinical settings by healthcare professionals to provide a barrier against contamination. Protects both patient and examiner during medical examinations. No electronic or software components.

## Clinical Evidence

Bench testing only. No clinical data provided. Performance verified against ASTM D6319-19, ASTM D5151-06, and ASTM D6124-06 standards. Biocompatibility testing performed per ISO 10993-5, ISO 10993-10, and ISO 10993-11.

## Technological Characteristics

Material: Nitrile with Titanium Dioxide pigment. Form factor: Ambidextrous, powder-free, various sizes (XS-XXXL). Standards: ASTM D6319-19 (physical properties, dimensions), ASTM D5151-06 (water tight test), ASTM D6124-06 (powder content). Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-11 (acute systemic toxicity).

## Regulatory Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

## Predicate Devices

- Powder Free Nitrile Examination Glove White ([K142858](/device/K142858.md))
- Powder Free Nitrile Examination Glove Blue ([K142862](/device/K142862.md))

## Submission Summary (Full Text)

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August 20, 2021

Careplus (M) SDN BHD Bee Khoo Quality Manager Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban. 70450 Mv

Re: K201857

Trade/Device Name: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 8, 2021 Received: July 12, 2021

Dear Bee Khoo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201857

Device Name

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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## K201857

## 510(K) SUMMARY

- 1.0 Applicant: CAREPLUS (M) SDN BHD
Address: Lot 120 & 121 . Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.

Phone No. 60-6-6772781 Fax No. 60-6-6772780

Contact Person Lim Kwee Shyan

- 2.0 Date of Summary 18th June, 2021
- 3.0 Device Information Device Name

## POWDER FREE NITRILE EXAMINATION GLOVE BLACK AND DUAL COLOR WHITE-BLUE

| Common Name          | : Exam Gloves                                       |
|----------------------|-----------------------------------------------------|
| Classification Name  | : Patient Examination Gloves (21 CFR 880.6250, LZA) |
| Classification Panel | : Non-powdered patient examination glove            |
| Class                | : I                                                 |

#### 4.0 Predicate Device

Predicate device: Powder Free Nitrile Examination Glove White, 510(k) number K142858 and Powder Free Nitrile Examination Glove Blue, 510(k) number K142862, product code LZA.

#### 5.0 Device Description

Powder Free Nitrile Examination Glove, Black and dual color White-Blue are Class 1 Patient Examination Gloves. The dual color White-Blue is made dual color by double dipping. They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large, Double Extra-Large and Triple Extra-Large. Gloves meet the ASTM D6319-19 specification below:

| Size               | XS | S   | M    | L   | XL  | XXL | XXXL |
|--------------------|----|-----|------|-----|-----|-----|------|
| Length, min. mm    |    | 220 |      | 230 |     |     | NA   |
| Thickness, min. mm |    |     |      |     |     |     |      |
| finger             |    |     | 0.05 |     |     |     | NA   |
| palm               |    |     | 0.05 |     |     |     |      |
| Width, ± 10 mm     | 70 | 80  | 95   | 110 | 120 |     | NA   |

#### 6.0 Indications for Use Statement

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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# K201857

## 7.0 Technological Characteristics

Following is a table summarized the technological characteristics compared to Predicate Device and equivalent standards:

| Parameter                                                                          | Standard<br>Reference                | Standard<br>Specification | Subject Glove<br>(Powder Free<br>Nitrile Examination<br>Glove, Black)<br>K201857                                              | Subject Glove<br>(Powder Free<br>Nitrile Examination<br>Glove, Dual Color<br>White-Blue)<br>K201857                           | Predicate Device<br>(Nitrile Blue,<br>K142862<br>Nitrile White,<br>K142858)                                                   | Characteristics |
|------------------------------------------------------------------------------------|--------------------------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Product Code<br>Regulation number                                                  | -                                    | -                         | LZA<br>21 CFR 880.6250                                                                                                        | LZA<br>21 CFR 880.6250                                                                                                        | LZA<br>21 CFR 880.6250                                                                                                        | Same            |
| Class                                                                              | -                                    | -                         | I                                                                                                                             | I                                                                                                                             | I                                                                                                                             | Same            |
| Material                                                                           | -                                    | -                         | Nitrile                                                                                                                       | Nitrile                                                                                                                       | Nitrile                                                                                                                       | Same            |
| Color                                                                              | -                                    | -                         | Black                                                                                                                         | White-Blue                                                                                                                    | Blue, White                                                                                                                   | Similar         |
| White Pigment                                                                      | -                                    | -                         | Titanium Dioxide                                                                                                              | Titanium Dioxide                                                                                                              | Titanium Dioxide                                                                                                              | Same            |
| Size                                                                               | ASTM<br>D6319-19                     | -                         | XS,S,M,L,XL, XXL,<br>XXXL                                                                                                     | XS,S,M,L,XL, XXL,<br>XXXL                                                                                                     | XS,S,M,L,XL                                                                                                                   | Similar         |
| Water Tight Test,<br>1000ml                                                        | ASTM<br>D6319-19<br>ASTM<br>D5151-06 | G-I, AQL 2.5              | Meets specification                                                                                                           | Meets specification                                                                                                           | Meets specification                                                                                                           | Same            |
| Physical Properties<br>i) Before Ageing<br>Tensile Strength<br>Ultimate Elongation | ASTM<br>D6319-19                     | Min. 14 Mpa<br>Min. 500 % | Meets specification                                                                                                           | Meets specification                                                                                                           | Meets specification                                                                                                           | Same            |
| ii) After Ageing<br>ii)Tensile Strength<br>Ultimate Elongation                     | ASTM<br>D6319-19                     | Min. 14 Mpa<br>Min. 500   | Meets specification                                                                                                           | Meets specification                                                                                                           | Meets specification                                                                                                           | Same            |
| Powder Content                                                                     | ASTM<br>D6319-19<br>ASTM<br>D6124-06 | Max.<br>2 mg/glove        | Meets specification                                                                                                           | Meets specification                                                                                                           | Meets specification                                                                                                           | Same            |
| Biocompatability<br>Test<br>i) Primary Skin<br>Irritation Test                     | ISO 10993-<br>10                     |                           | Conclusion: Under<br>the conditions of this<br>study, the test<br>material did not<br>cause and irritant<br>response.         | Conclusion: Under<br>the conditions of this<br>study, the test<br>material did not<br>cause and irritant<br>response.         | Conclusion: Under<br>the conditions of this<br>study, the test<br>material did not<br>cause and irritant<br>response.         | Same            |
| ii) Dermal<br>Sensitization Test                                                   | ISO 10993-<br>10                     |                           | Conclusion: Under<br>the conditions of this<br>study, the test<br>material did not<br>produce a skin<br>sensitization effect. | Conclusion: Under<br>the conditions of this<br>study, the test<br>material did not<br>produce a skin<br>sensitization effect. | Conclusion: Under<br>the conditions of this<br>study, the test<br>material did not<br>produce a skin<br>sensitization effect. | Same            |
| iii) Acute Systemic<br>Toxicity                                                    | ISO 10993-<br>11                     |                           | Conclusion: Under<br>the conditions of this<br>study, the test<br>material both inner<br>and outer surface<br>did not reveal  | Conclusion: Under<br>the conditions of this<br>study, the test<br>material both inner<br>and outer surface<br>did not reveal  | Conclusion: Under<br>the conditions of this<br>study, the test<br>material both inner<br>and outer surface<br>did not reveal  | Same            |

{5}------------------------------------------------

# K201857

| iv) In vitro Cytotoxicity<br>Test | ISO 10993-5 | Conclusions: Under<br>the conditions of this<br>study, the test<br>material is<br>Cytotox(grade >2) at<br>undiluted, 1:2, and<br>Non-cyctotoxic,<br>grade ≤2 at dilutions<br>1:4, 1:8;1:16,1:32<br>and 1:64        | Conclusions: Under<br>the conditions of this<br>study, the test<br>material is<br>Cytotox(grade >2) at<br>undiluted, 1:2, 1:4,<br>1:8 and Non-<br>cyctotoxic, grade ≤2<br>at dilutions;1:16,1:32<br>and 1:64       | White Nitrile:<br>Conclusions: Under<br>the conditions of this<br>study, the test<br>material is<br>Cytotox(grade >2) at<br>undiluted, 1:2, 1:4<br>and Non-cyctotoxic,<br>grade ≤2 at<br>dilutions, 1:8 ,<br>1:16,1:32 and 1:64<br><br>Blue Nitrile:<br>Conclusions: Under<br>the conditions of this<br>study, the test<br>material is<br>Cytotox(grade >2) at<br>undiluted, 1:2, 1:4,<br>1:8, 1:16 and Non-<br>cyctotoxic, grade ≤2<br>at dilutions;1:32 and<br>1:64 | Similar |
|-----------------------------------|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Single Use                        | -           | Single Use                                                                                                                                                                                                         | Single Use                                                                                                                                                                                                         | Single Use                                                                                                                                                                                                                                                                                                                                                                                                                                                            | Same    |
| Labeling                          | -           | Single Use                                                                                                                                                                                                         | Single Use                                                                                                                                                                                                         | Single Use                                                                                                                                                                                                                                                                                                                                                                                                                                                            | Same    |
| Intended Use                      | -           | A patient<br>examination gloves<br>is a disposal device<br>intended for medical<br>purposes that is<br>worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | A patient<br>examination gloves<br>is a disposal device<br>intended for medical<br>purposes that is<br>worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | A patient<br>examination gloves<br>is a disposal device<br>intended for medical<br>purposes that is<br>worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner.                                                                                                                                                                                                                                                    | Same    |

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| Parameter                          | Standard References | Standard Specification                                                                               | Device Performance<br>Black                                                             | Device Performance<br>White-Blue                                                        | Predicate Device   |
|------------------------------------|---------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------|
| Freedom from pin-holes             | ASTM D6319-19       | AQL 2.5                                                                                              | 1.5 and below                                                                           | 1.5 and below                                                                           | 1.5 and below      |
| Width, mm                          | ASTM D6319-19       | XS - 70 ± 10<br>S - 80 ± 10<br>M - 95 ± 10<br>L - 110 ± 10<br>XL- 120 ± 10<br>XXL- NA<br>XXXL- NA    | 78- 80<br>86- 88<br>96- 98<br>106- 108<br>116- 118<br>120- 125<br>126- 129              | 78- 80<br>86- 88<br>95- 98<br>107- 108<br>115- 117<br>122- 123<br>129- 132              | Meet Specification |
| Length, mm                         | ASTM D6319-19       | XS - 220 min<br>S - 220 min<br>M - 230 min<br>L - 230 min<br>XL- 230 min<br>XXL- NA<br>XXXL- NA      | min. 293<br>min. 285<br>min. 287<br>min. 281<br>min. 282<br>min. 292<br>min. 290        | min. 297<br>min. 285<br>min. 285<br>min. 286<br>min. 301<br>min. 289<br>min. 300        | Meet Specification |
| Thickness Palm, mm                 | ASTM D6319-19       | XS – 0.05 min<br>S - 0.05 min<br>M - 0.05 min<br>L - 0.05 min<br>XL- 0.05 min<br>XXL- NA<br>XXXL- NA | min. 0.13<br>min. 0.15<br>min. 0.15<br>min. 0.16<br>min. 0.15<br>min. 0.12<br>min. 0.13 | min. 0.15<br>min. 0.16<br>min. 0.15<br>min. 0.15<br>min. 0.14<br>min. 0.16<br>min. 0.14 | Meet Specification |
| Thickness Finger, mm               | ASTM D6319-19       | XS – 0.05 min<br>S - 0.05 min<br>M - 0.05 min<br>L - 0.05 min<br>XL- 0.05 min<br>XXL- NA<br>XXXL- NA | min. 0.18<br>min. 0.21<br>min. 0.21<br>min. 0.18<br>min. 0.21<br>min. 0.16<br>min. 0.20 | min. 0.19<br>min. 0.20<br>min. 0.19<br>min. 0.20<br>min. 0.20<br>min. 0.20<br>min. 0.19 | Meet Specification |
| Tensile Strength Before aging, Mpa | ASTM D6319-19       | 14 min                                                                                               | min. 25                                                                                 | min. 25                                                                                 | Meet Specification |
| Tensile Strength After aging, Mpa  | ASTM D6319-19       | 14 min                                                                                               | min. 29                                                                                 | min. 26                                                                                 | Meet Specification |
| Ultimate Elongation Before aging,% | ASTM D6319-19       | 500 min                                                                                              | min. 605                                                                                | min. 606                                                                                | Meet Specification |
| Ultimate Elongation After aging,%  | ASTM D6319-19       | 400 min                                                                                              | min. 559                                                                                | min. 576                                                                                | Meet Specification |
| Powder Free                        | ASTM D6319-19       | Max. 2                                                                                               | Max. 1.02                                                                               | Max. 0.90                                                                               | Meet Specification |

#### Summary of Non-Clinical Testing 8.0

The performance test data from the non-clinical test met the specifications from ASTM testing methodology.

#### Summary of Clinical Testing 9.0

Clinical data is not needed for medical gloves or of most devices cleared by the 510(k) process.

### 10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.

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**Source:** [https://fda-staging.innolitics.com/device/K201857](https://fda-staging.innolitics.com/device/K201857)

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